Participation in another clinical trial in the last 30 days before starting this trial (i. e., first administration of IMP)

Positive drug of abuse screening

Diseases or condition known to interfere with the absorption, distribution, metabolism or excretion of drugs

Marked repolarisation abnormality (e.g., suspicious or definite congenital long QT syndrome with QT/QTc>500msec or prolonged QTc, i.e.>450msec) or co- medication that is known to influence cardiac repolarisation substantially

Bronchial asthma

Definite or suspected history of drug allergy or hypersensitivity

Subjects who have received any prescribed and non-prescribed systemic or topical medication like analgesics, NSAIDs (except standard dose of a NSAID once a week for the treatment of headache), hypnotics, sedatives, narcotics, neuroleptics or other medications that may lower the seizure threshold, MAO- inhibitors, serotonin-reuptake-inhibitors, tricyclic antidepressants, other centrally acting substances and substances which are known to interact with the drug metabolizing enzymes (e.g., inhibitors or inducers of CYP3A4 or CYP2D6) four weeks prior to the start of the trial (i.e. first administration of IMP). Each case has to be decided upon individually by the investigator after consultation with the Sponsor

Blood loss (> 100 ml) due to e.g. blood donation within 3 months before starting this trial (i.e., first administration of IMP)

History of seizures or at risk (i.e. head trauma, epilepsy in family anamnesis, unclear loss of consciousness)

Known or suspected of not beeing able to comply with the trial protocol

Not able to communicate meaningfully with the investigator and statt

Smoking of > 10 cigarettes/day or equivalent

Trial specific exclusion criteria:

Subjects not able to abstain from strenuous exercise during the whole course of the trial

Abnormality (e.g. scar, tattoo) or unhealthy skin at application site according to examination by the investigator

Existing chronic skin disease or history of skin disease at the application site within the last 4 weeks

Presence of one of the contraindications as detailed in the current Summary of Product Characteristics (SmPC)

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00388219